Device recall
Z-0679-03: Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two…
FDA device recall · Class II · Abbott Laboratories HPD/ADD
Key facts
| Recall number (Z-number) | Z-0679-03 |
|---|---|
| Recall event | 25690 |
| Product | Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | MOI |
| Recalling firm | Abbott Laboratories HPD/ADD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2004 |
| 510(k) numbers | K963926 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database